BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3970983 · Received July 31, 2014

    Report

    Report Number
    1531186-2014-02895
    Date Received
    July 31, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 23, 2014
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATES THE SEAT HAS CRACKED IN HALF AND PINCHING HER MOTHER'S BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448197 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX AQUATEC OPERATIONS GMBH 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other